Comparison Study of Insulin GZR4 With Insulin Degludec
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGan and Lee Pharmaceuticals, USA
About this trial
In this study, the investigational product will be compared with insulin degludec (Tresiba®) and insulin icodec (Awiqli®). The comparator products are approved for the treatment of T2DM in the European Union.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
GZR4 injection
DrugGZR4 is a new ultra-long-acting insulin analog
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: All participants will receive all three treatments in a fixed-sequence design.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To investigate the PD of GZR4 compared to insulin degludec at steady state
AUCGIR.0-24h.ss, area under the glucose infusion rate curve over one dosing interval from 0 to 24 hours at steady state for insulin degludec AUCGIR.0-168h.ss, area under the glucose infusion rate curve over one dosing interval from 0 to 168 hours at steady state for GZR4
Time frame
0 - 24 hours for Degulec 0-168 hours for GZR4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gan and Lee Pharmaceuticals, USA
Lead sponsor
Profil Institut für Stoffwechselforschung GmbH
Collaborator
Source ClinicalTrials.gov